This Structured Product Labeling (SPL) webinar will provide valuable assistance and a road map to device companies who need to learn how to properly create product and patient labeling information and meet minimum compliance expectations.

Why should you Attend: What is medical device patient labeling? Why is medical device patient labeling important? What are the general types of information that may be included in medical device patient labeling? When should you use medical device patient labeling? When is medical device patient labeling not usually necessary? What should you consider when identifying a method to distribute the medical device patient labeling? What content goes into your product label and will it meet Agency requirements? Furthermore, the FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing.

FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information. This session, as an added bonus, will address SPL documents and general expectations for manufacturers. Pharmaceutical companies have moved in varying degrees to the tagged-content XML format for managing content internally, submitting documents to FDA in Structured Product Labeling (SPL) format, and meeting Europe’s Product Information Management (PIM) standard.

All labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce. The term "accompanying" is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. "Accompanying" also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

This Product Labeling session will address what you need to do to ensure compliance. The label is a "display of written, printed, or graphic matter upon the immediate container of any article..." As a bonus, this session will also address SPL and one of the advantages of SPL (over the PDF format that FDA previously used) is that it will make exchange of labeling changes more efficient. Only the sections or data elements that are changed would require checking, FDA notes. Comparison of text by section and of specific drug information data elements can be automated. SPL also supports health information technology initiatives for improving patient care.

Areas Covered in the seminar:

What goes into the label and does it meet regulatory requirements?

Understand the labeling requirements and expectations.

Learn and apply device labeling requirements under QSR and other CFR statutory requirements.

General labeling guidance documents and what to expect.

Special tips and why writing style, content and formatting are important.

Understand adequate directions for use, operating and servicing instructions and health warnings to protect end user/patient.

Learn and apply device labeling requirements under QSR and other CFR statutory requirements.

Learn why and how SPL allows electronic edit, search, review, and archiving of drug labeling and why SPL is a timely topic.

Who will benefit:

This webinar will provide valuable assistance and guidance to companies who need to better understand product labeling requirements and the impact of SPL on labeling operations. The employees who will benefit include:

All end-users from appropriate departments who desire or require a better understanding or more of an advanced "refresh" overview of how to create and manage the product labeling process more effectively and in a state of compliance.

QA and Compliance

Regulatory Affairs Management and RA Specialists

Marketing

Consultants

Technical Writers and employees who review labeling content

Instructor Profile:David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

Key areas of focus also include product development and commercialization strategies, regulatory classifications, applications and submissions, rapid regulatory crisis response, and inspection readiness preparedness for manufacturers. He adds business value to device companies by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. The focus is on planning, implementation, and training for all phases of the regulatory review and approval process, and on minimizing delays due to regulatory noncompliance.

He has a proven track record and an accomplished regulatory professional working not only with several Notified Bodies and FDA/CDRH/ODE representatives but also international regulatory bodies in Japan, EU, Australia, Canada and other locales. He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

Mr. Dills’ academic degrees include Environmental Science and Biology. He currently serves as Advisor for the ASQ’s Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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